MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION ANGIO-SEAL; DEVICE, HEMOSTASIS, VASCULAR

Model Number	610131
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pseudoaneurysm (2605)
Date of Event	02/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6b: explanted date: device was not explanted.E3: occupation: interventional radiologist.The actual device was not available; therefore, the actual device will not be returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.
Event or Problem Description
Terumo medical corporation received the following information: it was reported that the patient arrived in the emergency room with a cold leg on (b)(6) 2026.An aorta with bilateral lower leg angiogram was performed.Left groin access was chosen because of right leg being symptomatic.A 4fr micropuncture kit was used to gain access and a 5 fr x 10cm pinnacle sheath was inserted.An angiogram was performed and it was determined the patient needed thrombolysis.The 5fr sheath was replaced with an 8fr x 45cm destination sheath.Thrombolysis was performed with the inari system.Upon completing thrombolysis, a left groin angiogram was performed and an 8fr angio-seal vip was successfully deployed without incident.The patient was discharged on (b)(6) 2026, in stable condition.The patient arrived in the emergency room again on (b)(6) 2026, with a hard left sided groin.When ultrasound was performed, a pseudoaneurysm was seen over the site of the angio-seal deployment.Ultrasound picture was obtained.Thrombin was injected into the sac of the aneurysm, the bleeding stopped and the patient was sent home in stable condition.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The sample was not available for evaluation.One photo was provided showing the pseudoaneurysm.No determination could be made based on the available radiographic image.The cause of the event could not be identified based on the available information.The complaint was confirmed for closure procedural complication.The exact root cause cannot be determined.Review of device history record showed there were no issues noted during the manufacture of the product that could have contributed to this complaint condition.Currently, no action is recommended since this risk evaluation is within the predetermined limits in the failure mode and effects analysis (fmea)/hazard based risk table (hbrt).

• Brand Name: ANGIO-SEAL
• Common Device Name: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 265 davidson ave; suite 320; somerset NJ 08873
• Manufacturer (Section G): TERUMO PUERTO RICO LLC; innovacion street lot 21; caguas west industrial park; caguas, 00725
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 24678430
• Report Number: 3013394970-2026-00130
• Device Sequence Number: 5079930
• Product Code: MGB
• UDI-Device Identifier: 00389701011813
• UDI-Public: (01)00389701011813(17)260430(10)0001069368
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P930038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: 610131
• Device Catalogue Number: 610131
• Device Lot Number: 0001069368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4FR MICROPUNCTURE KIT; 5FR OMNIFLUSH CATHETER; 5FR X 10CM PINNACLE SHEATH; 8FR X 45CM DESTINATION SHEATH; ROSEN WIRE
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White